Adapted from “DTC Ad Spend,” © 2010 Pharma Marketing News.
The Need for Increased Regulation of Direct-to- Consumer Genetic Testing
With the rapid expansion of scientific knowledge
regarding the human genome, genetic testing has become
a common method for screening, testing, and diagnosing a
number of inherited diseases. Some companies have even
begun selling genetic tests directly to consumers: a method
referred to as “direct-to-consumer” (DTC) genetic testing.
The benefits of DTC testing include the accessibility of the
tests and the promotion of proactive healthcare by consumers.
However, additional government regulation of DTC tests is
necessary in order to ensure that the tests remain accurate
and that consumers are not misled about their health.
In order to provide useful information to consumers,
DTC tests need to be both accurate and 1 reliable. However,
until recently, government regulation of DTC tests has
focused on how these tests are advertised to the public rather
than the validity of the tests themselves. Thankfully, in 2014,
the Food and Drug Administration (FDA) unveiled a plan to
increase the regulation of thousands of laboratory-developed
tests, including many DTC tests. The 2 essential necessity
of such increased regulation cannot be overstated. In a 2006
investigation, for example, the Government Accountability
Office found that some anonymous donors were given vastly
different results from a sample of four DTC tests. 3
In addition to improving the validity of DTC tests,
government regulation would also help to prevent the
potential misinterpretation of test results by consumers.
Even with a detailed breakdown of someone’s genome, it is
impossible for anyone—including physicians—to know how
all of those genes will interact with one another and how
various environmental factors will mediate 4 their effects.
Thus, government regulation is necessary in order to ensure
that consumers are properly educated about the limitations of
DTC testing. The FDA has accomplished this, to some degree,
by regulating how DTC tests are advertised to the public.
Following the GAO investigation, for example, spending on
DTC advertisements 5 was cut in half between 2006 and
2009. However, further communication is needed between
consumers, physicians, and DTC testing companies in order
to safeguard consumers from making potentially harmful
decisions about their health.
The Need for Increased Regulation of Direct-to- Consumer Genetic Testing
With the rapid expansion of scientific knowledge
regarding the human genome, genetic testing has become
a common method for screening, testing, and diagnosing a
number of inherited diseases. Some companies have even
begun selling genetic tests directly to consumers: a method
referred to as “direct-to-consumer” (DTC) genetic testing.
The benefits of DTC testing include the accessibility of the
tests and the promotion of proactive healthcare by consumers.
However, additional government regulation of DTC tests is
necessary in order to ensure that the tests remain accurate
and that consumers are not misled about their health.
In order to provide useful information to consumers,
DTC tests need to be both accurate and 1 reliable. However,
until recently, government regulation of DTC tests has
focused on how these tests are advertised to the public rather
than the validity of the tests themselves. Thankfully, in 2014,
the Food and Drug Administration (FDA) unveiled a plan to
increase the regulation of thousands of laboratory-developed
tests, including many DTC tests. The 2 essential necessity
of such increased regulation cannot be overstated. In a 2006
investigation, for example, the Government Accountability
Office found that some anonymous donors were given vastly
different results from a sample of four DTC tests. 3
In addition to improving the validity of DTC tests,
government regulation would also help to prevent the
potential misinterpretation of test results by consumers.
Even with a detailed breakdown of someone’s genome, it is
impossible for anyone—including physicians—to know how
all of those genes will interact with one another and how
various environmental factors will mediate 4 their effects.
Thus, government regulation is necessary in order to ensure
that consumers are properly educated about the limitations of
DTC testing. The FDA has accomplished this, to some degree,
by regulating how DTC tests are advertised to the public.
Following the GAO investigation, for example, spending on
DTC advertisements 5 was cut in half between 2006 and
2009. However, further communication is needed between
consumers, physicians, and DTC testing companies in order
to safeguard consumers from making potentially harmful
decisions about their health.